BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURGE CASSETTE

    MDR report key: 23923328 · Received December 30, 2025

    Report

    Report Number
    1220648-2025-49548
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 1, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE INVESTIGATION WAS COMPLETED AND NOTED A DEVICE HISTORY RECORD REVIEW CONFIRMED THE DEVICE PASSED ALL THE POST STERILE INSPECTION CHECKS. CP PUMP SN: (B)(6) & PC WERE RETURNED FOR REVIEW. ON THE SAME DAY AS IMPLANT, PURGE PRESSURE LOW ALARM OCCURRED. PURGE PRESSURE 62MMHG, LEAKING ON PURGE CASSETTE. PURGE CASSETTE REPLACED, ISSUE SOLVED. DATA LOGS WERE RECOVERED AND THE RT LOG SHOWED PURGE ALARMS RESOLVE AFTER A DE-AIR PROCEDURE THAT FOLLOWED 10 MINUTES OF PURGE RELATED ALARMS AND ISSUES. RAW PURGE REMAINED ELEVATED EVEN AFTER THE PURGE PRESSURE RESOLVED. RETURNED IMC LOGS SHOWED THE PURGE CASSETTE S/N (B)(6) LOT 1982102 WAS THE PC USED TO RESOLVE THE PURGE ISSUES. PRIOR USED PURGE CASSETTE S/N (B)(6) LOT 1986892 WAS USED AT INITIAL CASE START THAT EXPERIENCED THE REPORTED ISSUES. NO ADDITIONAL PURGE CASSETTES WERE USED OVER THE 1 HOUR DURATION OF THE CASE AND THE CP WAS WEANED SUCCESSFULLY. THE PURGE CASSETTE S/N (B)(6) LOT 1982102 WAS THE PC USED TO RESOLVE THE PURGE ISSUES AND WAS RETURNED AND INSPECTED AND SHOWED NO PHYSICAL ABNORMALITIES. PUMP S/N (B)(6) AND PURGE CASSETTE WERE RUN IN THE LAB WITH NO ISSUES NOTED WITH THE PURGE METRICS. PURGE PRESSURE LOW ALARM WAS UNABLE TO BE TRIGGERED. DURING THE 15 MINUTES THE PUMP WAS PURGING, A SMALL PURGE LEAK WAS NOTED TO ORIGINATE FROM THE PURGE SIDEARM, BETWEEN THE FILER AND THE RED HANDLE. THIS LEAK HAD NO IMPACT ON PURGE PERFORMANCE. PURGE PRESSURE LOW - THE CAUSE OF THE PURGE PRESSURE LOW WAS NOT DETERMINED DUE TO NO PRODUCT BEING RETURNED FOR THE PURGE CASSETTE WITH THE PURGE PRESSURE LOW ALLEGATION, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS. FLUID LEAK - THE CAUSE OF THE FLUID LEAK WAS NOT DETERMINED DUE TO NO PRODUCT BEING RETURNED FOR THE PURGE CASSETTE WITH THE FLUID LEAK ALLEGATION, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). UPON REVIEW, IT WAS IDENTIFIED ADDITIONAL INFORMATION HAS BEEN ADDED TO THIS REPORT. CORRECTED INFORMATION WAS PROVIDED IN B1 (IS ADVERSE EVENT) AND B2 (IS REQUIRED INTERVENTION). UPON REVIEW, IT WAS IDENTIFIED THAT THE REPORTABILITY STATUS HAD CHANGED. CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D CATALOG NUMBER HAS NOW BEEN PROVIDED. CORRECTED INFORMATION WAS PROVIDED IN H1 (TYPE OF REPORTABLE EVENT). UPON REVIEW, IT WAS IDENTIFIED THAT THE REPORTABILITY STATUS HAD CHANGED. CORRECTED INFORMATION WAS PROVIDED IN H3 (DEVICE EVALUATED BY MANUFACTURER?). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED IN ERROR IN THE FOLLOW REPORT. ADDITIONAL INFORMATION WAS PROVIDED IN H6 (HEALTH EFFECT - CLINICAL CODE). UPON REVIEW, IT WAS IDENTIFIED THAT THE CODE HAS BEEN ADDED TO THIS REPORT. ADDITIONAL INFORMATION WAS PROVIDED IN H6 (HEALTH EFFECT - IMPACT CODE). UPON REVIEW, IT WAS IDENTIFIED THAT THE CODE HAS BEEN ADDED TO THIS REPORT. THE CAUSE OF THE PURGE PRESSURE LOW WAS NOT DETERMINED DUE TO NO PRODUCT BEING RETURNED FOR THE PURGE CASSETTE WITH THE PURGE PRESSURE LOW ALLEGATION, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE FLUID LEAK WAS NOT DETERMINED DUE TO NO PRODUCT BEING RETURNED FOR THE PURGE CASSETTE WITH THE FLUID LEAK ALLEGATION, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE G3. DATE RECEIVED BY MANUFACTURER WAS INCORRECTLY REPORTED WITHIN FOLLOW UP NUMBER 2 OF MRN NUMBER 1220648-2025-49548. THE CORRECT DATE IS 27-02-2026, WHICH MAKES THE REPORT SUBMISSION DUE DATE TO BE 29-03-2026.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THE IMPELLA DEVICE INSERTED VIA PERCUTANEOUS RIGHT FEMORAL ARTERIAL ACCESS. THE PROCEDURE WAS SUCCESSFUL WITH NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS EXPERIENCING RED ALARM PURGE PRESSURE LOW OCCURRED. PURGE PRESSURE WAS 62MMHG, LEAKING ON PURGE SIDE ARM. PURGE CASSETTE REPLACED, ISSUE SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001419 PURGE CASSETTE TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PURGE CASSETTE 1986833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown